UMIN ID: UMIN000001517
Registered date:20/11/2008
Multicenter comparative between 5 and 15 backward-oblique angle of duodenoscope for ERCP
Basic Information
| Recruitment status | Complete: follow-up complete |
|---|---|
| Health condition(s) or Problem(s) studied | Pancreaticobiliary disease |
| Date of first enrollment | 2008/09/01 |
| Target sample size | 200 |
| Countries of recruitment | Japan |
| Study type | Interventional |
| Intervention(s) | Duodenoscope Papillotome knife |
Outcome(s)
| Primary Outcome | The main outcome measurement was successful or failed selective cannulation of the CBD with wire-guided catheter or hydrophilic guidewire within a period of 10 minutes. |
|---|---|
| Secondary Outcome |
Key inclusion & exclusion criteria
| Age minimum | 20years-old |
|---|---|
| Age maximum | Not applicable |
| Gender | Male and Female |
| Include criteria | |
| Exclude criteria | Exclusion criteria were the following: severe disturbance of consciousness; age below 20 years, acute illness (hypotension: systolic blood pressure below 90mmHg; hypoxia: oxygen saturation less than 95% on supplemental oxygen; hemodynamic instability), disseminated intravascular coagulation; sepsis; acute circulatory failure; severe heart disease; hepatic insufficiency, compromised renal dysfuncion; a previous ERCP; acute pancreatitis; acute exacerbation of chronic pancreatitis; common bile duct stone impaction; ampullary neoplasm; Billroth II gastrectomy; Roue-en-Y reconstruction; separate orifices of the CBD and pancreatic duct on the papilla; pregnancy; breast-feeding women; women suspected of being pregnancy; refusal to participate in the study. Somebody who are found unifit to be patients by investigator |
Related Information
| Primary Sponsor | Hokkaido University Graduate School of Medicine |
|---|---|
| Secondary Sponsor | |
| Source(s) of Monetary Support | None |
| Secondary ID(s) |
Contact
| public contact | |
| Name | Hiroshi Kawakami |
| Address | Kita 14, Nishi 5, Kita-ku, Sapporo 060-8638, Japan Japan |
| Telephone | |
| Affiliation | Hokkaido University Hospital Department of Gastroenterology |
| scientific contact | |
| Name | Hiroshi Kawakami |
| Address | Kita 15, Nishi 7, Kita-ku, Sapporo 060-8638, Japan Japan |
| Telephone | 011-716-1161 |
| Affiliation | Hokkaido University Graduate School of Medicine Department of Gastroenterology |